ACTIVA

Vehicle, Motorized 3-wheeled

HOVEROUND CORP.

The following data is part of a premarket notification filed by Hoveround Corp. with the FDA for Activa.

Pre-market Notification Details

• Device ID: K991132
• 510k Number: K991132
• Device Name: ACTIVA
• Classification: Vehicle, Motorized 3-wheeled
• Applicant: HOVEROUND CORP. 2151 WHITFIELD INDUSTRIAL WAY Sarasota, FL 34243
• Contact: Stan Cooper
• Correspondent: Stan Cooper; HOVEROUND CORP. 2151 WHITFIELD INDUSTRIAL WAY Sarasota, FL 34243
• Product Code: INI
• CFR Regulation Number: 890.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-02
• Decision Date: 1999-10-20
• Summary: summary